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A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke
Sponsor: Shanghai Zhongshan Hospital
Summary
This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development. Study Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year. The expected duration of participation for each participant is approximately 6 months.
Key Details
Gender
All
Age Range
18 Days - Any
Study Type
INTERVENTIONAL
Enrollment
306
Start Date
2026-02-08
Completion Date
2027-12-31
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Intra-operative application of LAAC
Undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.